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510(k) K945421

CHAKOFF ENDOSCOPY by Stephen Chakoff, Inc. — Product Code FDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1994
Date Received
November 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Fiberoptic
Device Class
Class I
Regulation Number
876.4530
Review Panel
GU
Submission Type

Other clearances by Stephen Chakoff, Inc.

  • K940316 — HYSTERSCOPE (November 16, 1995)
  • K940317 — SINUSCOPE (May 24, 1995)
  • K950753 — CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO (May 15, 1995)
  • K951082 — CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE (March 22, 1995)
  • K950744 — CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE) (March 6, 1995)
  • K950748 — CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) (March 6, 1995)
  • K950747 — CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) (March 6, 1995)
  • K950745 — CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES) (March 6, 1995)
  • K950746 — CHAKOFF ENDOSCOPY (SET LAPAROSCOPY) (March 6, 1995)
  • K945420 — CHAKOFF ENDOSCOPY (December 8, 1994)

Other clearances for product code FDG

  • K964561 — ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, (February 11, 1997)